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Drug Promotion: M&A, Old Social Media Posts Can Increase Risk Of US FDA Enforcement

 
• By Sue Sutter

The loss of institutional knowledge about OPDP’s prior comments on promotional materials can result in an enforcement letter for the new owner of a company or product, experts say.

Elephant in the room
Like an elephant, the FDA never forgets what it tells sponsors about their promotional campaigns. (Shutterstock)
Key Takeaways
  • A merger or acquisition can result in a loss of institutional knowledge about the FDA’s prior comments on a product’s promotional materials, which can lead to an enforcement letter.
  • Promotional violations following M&A have sometimes resulted in warning letters.
  • Companies should remove social media posts from prior campaigns before the FDA or a competitor flags them for a potential violation, experts said.

A drug company’s risk of receiving a promotion enforcement letter from the US Food and Drug Administration may increase with corporate mergers and acquisitions and a failure to clear away...

Institutional knowledge about the FDA’s prior advice on advertising campaigns can disappear when companies merge or are acquired, which can lead to an enforcement letter based on the issues the...

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